Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Active as of 2022-05-28 |
<Evidence xmlns="http://hl7.org/fhir">
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<lastUpdated value="2023-12-06T17:46:14.323Z"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Evidence</b><a name="32144"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Evidence "32144" Version "20" Updated "2023-12-06 17:46:14+0000" </p><p style="margin-bottom: 0px">Profiles: <a href="StructureDefinition-comparative-evidence.html">ComparativeEvidence</a>, <a href="StructureDefinition-single-study-evidence.html">SingleStudyEvidence</a></p></div><p><b>StructureDefinition Work Group</b>: cds</p><p><b>url</b>: <code>https://fevir.net/resources/Evidence/32144</code></p><p><b>identifier</b>: FEvIR Object Identifier: 32144</p><p><b>version</b>: 1.0.0-ballot</p><p><b>name</b>: ComparativeEvidence_Bariatric_Surgery_effect_for_ADA_triple_outcome_at_5_years_Diabetes_Surgery_Study</p><p><b>title</b>: ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)</p><p><b>status</b>: active</p><p><b>date</b>: 2022-05-28 11:56:53+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>author</b>: Brian S. Alper: </p><p><b>copyright</b>: Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International</p><blockquote><p><b>relatedArtifact</b></p><p><b>type</b>: derived-from</p><p><b>label</b>: data source</p><p><b>display</b>: Diabetes Surgery Study</p><p><b>citation</b>: Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study [Journal Article]. Contributors: Sayeed Ikramuddin, Judith Korner, Wei-Jei Lee, Avis J Thomas, John E Connett, John P Bantle, Daniel B Leslie, Qi Wang, William B Inabnet, Robert W Jeffery, Keong Chong, Lee-Ming Chuang, Michael D Jensen, Adrian Vella, Leaque Ahmed, Kumar Belani, Charles J Billington. In: JAMA, PMID 29340678. Published January 16, 2018. Available at: https://pubmed.ncbi.nlm.nih.gov/29340678/.</p><blockquote><p><b>document</b></p></blockquote></blockquote><blockquote><p><b>relatedArtifact</b></p><p><b>type</b>: cite-as</p><p><b>citation</b>: ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study) [Evidence]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 32144. Revised 2022-05-28. Available at: https://fevir.net/resources/Evidence/32144. Computable resource at: https://fevir.net/resources/Evidence/32144.</p></blockquote><p><b>description</b>: Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01).</p><p><b>assertion</b>: In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement.</p><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: population</p><p><b>description</b>: Bariatric Surgery Trial Enrollment Group</p><p><b>note</b>: population</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#population "population")</span></p><p><b>observed</b>: <a href="Group-32145.html">Group/32145: 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011)</a> "StudyGroup_Bariatric_Surgery_Trial_Enrollment_Group"</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: exposure</p><p><b>VariableDefinitionComparatorCategory</b>: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years</p><p><b>description</b>: Group assignment</p><p><b>note</b>: exposure</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#exposure "exposure")</span></p><p><b>observed</b>: <a href="EvidenceVariable-172481.html">EvidenceVariable/172481: GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone</a> "GroupAssignment_Roux_en_Y_gastric_bypass_surgery_vs_Lifestyle_intensive_medical_management_intervention_alone"</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>VariableDefinitionVariableRoleCode</b>: outcome</p><p><b>description</b>: American Diabetes Association composite triple end point for metabolic control at 5 years *NOTE: note.text is used artificially to support the EBMonFHIR Implementation Guide and the following content would more properly be found in a note.text element:* The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years</p><p><b>note</b>: outcome</p><p><b>variableRole</b>: Use extension:variableRoleCode instead. <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-variable-role.html">EvidenceVariableRole</a>#measuredVariable "measured variable")</span></p><p><b>observed</b>: <a href="EvidenceVariable-32143.html">EvidenceVariable/32143: OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years</a> "OutcomeVariable_American_Diabetes_Association_composite_triple_end_point_for_metabolic_control_at_5_years"</p></blockquote><p><b>synthesisType</b>: not applicable <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-synthesis-type.html">StatisticSynthesisType</a>#NotApplicable)</span></p><p><b>studyDesign</b>: randomized assignment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-181513.html">Scientific Evidence Code System (SEVCO) -- EXAMPLE VERSION for EBMonFHIR Implementation Guide</a>#SEVCO:01003)</span></p><blockquote><p><b>statistic</b></p><p><b>description</b>: Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01).</p><p><b>statisticType</b>: Risk Difference <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (StatisticStatisticType[4.4.0]#0000424)</span></p><p><b>quantity</b>: 0.19</p><p><b>numberAffected</b>: 15</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>NumberOfStudies</b></td><td><b>NumberOfParticipants</b></td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>1</td><td>120</td><td>98</td></tr></table><h3>AttributeEstimates</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Level</b></td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>Confidence interval <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-attribute-estimate-type.html">StatisticAttribute Estimate Type</a>#C53324)</span></td><td>0.95</td><td>0.04-0.34</td></tr></table></blockquote></div>
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<title
value="ComparativeEvidence: Bariatric Surgery effect for ADA triple outcome at 5 years (Diabetes Surgery Study)"/>
<status value="active"/>
<date value="2022-05-28T11:56:53.907Z"/>
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<name value="Brian S. Alper"/>
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<label value="data source"/>
<display value="Diabetes Surgery Study"/>
<citation
value="Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study [Journal Article]. Contributors: Sayeed Ikramuddin, Judith Korner, Wei-Jei Lee, Avis J Thomas, John E Connett, John P Bantle, Daniel B Leslie, Qi Wang, William B Inabnet, Robert W Jeffery, Keong Chong, Lee-Ming Chuang, Michael D Jensen, Adrian Vella, Leaque Ahmed, Kumar Belani, Charles J Billington. In: JAMA, PMID 29340678. Published January 16, 2018. Available at: https://pubmed.ncbi.nlm.nih.gov/29340678/."/>
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<citation
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<description
value="Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01)."/>
<assertion
value="In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement."/>
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<description value="Bariatric Surgery Trial Enrollment Group"/>
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<code value="population"/>
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<reference value="Group/32145"/>
<type value="Group"/>
<display
value="120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011)"/>
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<description value="Group assignment"/>
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<variableRole>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
<code value="exposure"/>
<display value="exposure"/>
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<text value="Use extension:variableRoleCode instead."/>
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<observed>🔗
<reference value="EvidenceVariable/172481"/>
<type value="EvidenceVariable"/>
<display
value="GroupAssignment: Roux-en-Y gastric bypass surgery vs. Lifestyle-intensive medical management intervention alone"/>
</observed>
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<variableDefinition>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition-variable-role-code">
<valueCode value="outcome"/>
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<description
value="American Diabetes Association composite triple end point for metabolic control at 5 years *NOTE: note.text is used artificially to support the EBMonFHIR Implementation Guide and the following content would more properly be found in a note.text element:* The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years"/>
<note>
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<variableRole>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/variable-role"/>
<code value="measuredVariable"/>
<display value="measured variable"/>
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<text value="Use extension:variableRoleCode instead."/>
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<observed>🔗
<reference value="EvidenceVariable/32143"/>
<type value="EvidenceVariable"/>
<display
value="OutcomeVariable: American Diabetes Association composite triple end point for metabolic control at 5 years"/>
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<description
value="Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01)."/>
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<version value="4.4.0"/>
<code value="0000424"/>
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<userSelected value="true"/>
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<quantity>
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<numberAffected value="15"/>
<sampleSize>
<numberOfStudies value="1"/>
<numberOfParticipants value="120"/>
<knownDataCount value="98"/>
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<attributeEstimate>
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<code value="C53324"/>
<display value="Confidence interval"/>
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<level value="0.95"/>
<range>
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<value value="0.04"/>
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<high>
<value value="0.34"/>
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</range>
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</Evidence>
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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